Clinical Study of CALCiViS imaging system completed
CALCiViS , a medical devices company focused on revolutionising the management of tooth decay, today announces that it has completed a first clinical study of its CALCiViS imaging system.
The CALCiViS imaging system is a sophisticated medical device and consumable combination designed to transform the assessment and management of enamel demineralisation. It involves a unique, proprietary bioluminescence approach combined with a specialised imaging device which allows accurate detection and visualisation of demineralisation by imaging free calcium ions at the tooth surface; a caries lesion which is actively demineralising is more likely to progress and lead to cavitation. The CALCiViS imaging system has been granted a CE Mark.
The study was the first to evaluate the CALCiViS imaging system in a full clinical dental setting. It was conducted in 39 patients by four general dental practitioners based in three practices in Scotland. Full results and analysis will be completed early in 2015.
Charles Ormond, Principle Investigator, said: “It has been very interesting to be involved with a clinical study of this new technology in Scotland. The images have the potential to provide real insights into the ongoing demineralisation disease process.”
Adam Christie, CEO of CALCiViS , said: “The completion of our first clinical study is an important step for CALCiViS . We have previously seen excellent results in ex vivo and the new study has allowed us to gain extremely valuable real world experience in the use of the device and consumable. We will be analysing the results over the coming months and using the insights we gain as we continue to prepare for commercialisation.”
The CALCiViS imaging system is an in-clinic device which combines a sensitive intraoral camera and application technology to deliver a precise amount of CALCiViS photoprotein, onto the tooth surface.
The photoprotein binds calcium ions and emits a blue light signal proportional to the amount of calcium present. This exquisitely sensitive chemiluminescent system produces a demineralisation map of the tooth. The resulting images provide a focus for discussion with patients about their caries management programme and the development of a tailored, rational, evidence-based treatment in line with dental best practice.